Time: UTC 1400; 15:00 CET, 10:00 AM EST, 10:00 PM Singapore. We apologize for the inconvenient time in some regions.

Facilitator:Cinzia Piccini, Eli Lilly & Co, Spain

Open To: Staff from eClinical Forum member companies

Background: eClinical Forum Birds-of-a-Feather sessions focus on the details of a specific topic and are participative discussions, not presentations. All participants are encouraged to share information and ask questions. Any member can participate that has an interest in the topic area. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

For This Topic: The following questions will be discussed. If you have additional discussion questions for this topic, please type them in during your registration.

Description: According to Part 11, audit trails need to be available and convertible in a generally intelligible form, allowing regular reviews and copying by the agency. With the recent release of data integrity guidelines across GxP, audit trail reports are becoming a common request during GCP regulatory inspections. For GMP, Annex 11 dictates regular audit trail reviews; in GCP this is a non-written expectation as its content might help identify data anomalies and/or data integrity signals.

This is not a presentation but rather an open discussion: How much review of audit trail records is necessary? What are good practices, tool and education needs to perform a well-defined review? What is the focus of a review by the sponsor and by the agency? All questions and comments are welcome.

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